The following data is part of a premarket notification filed by Ergoline Gmbh with the FDA for Ers2 - Ergoline Rehabilitation System.
| Device ID | K212883 |
| 510k Number | K212883 |
| Device Name: | Ers2 - Ergoline Rehabilitation System |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | ergoline GmbH Lindenstrasse 5 Bitz, DE 72475 |
| Contact | Alexandra Lertz |
| Correspondent | Alexandra Lertz ergoline GmbH Lindenstrasse 5 Bitz, DE 72475 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-10 |
| Decision Date | 2022-07-15 |